MAUDE Adverse Event Report: BIOSENSE WEBSTER INC WEBSTER ® CS CATHETER WITH EZ STEER¿ TECHNOLOGY; ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE

Model Number	BD710FJ282RTS
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	05/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A device history record evaluation was performed for the finished device 30751210m number, and no internal actions related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) female patient underwent a supraventricular tachycardia (svt) ablation procedure with a webster ® cs catheter with ez steer¿ technology.The patient suffered cardiac tamponade requiring a pericardiocentesis.During the procedure, a cardiac tamponade was noticed before any ablation had occurred.The patient had a drop in blood pressure that occurred when they were getting ready to zero the ablation catheter and were performing respiratory training.The cardiac tamponade was confirmed by an echocardiogram.The medical intervention provided was a pericardiocentesis and just over 200 cc¿s of fluid were removed.The patient was reported to be in stable condition.There was no indication throughout the case of any issues besides the patient's drop in blood pressure.The physician believed the pericardial effusion may have occurred due to a perforation by the webster ® cs catheter with ez steer¿ technology.No ablation had occurred yet.Additional information was received.The physician¿s opinion on the cause of this adverse event was procedure and patient condition related.The patient outcome was fully recovered.The generator that was intended to be used was a smartablate.A transseptal puncture was not performed.No ablation was performed prior to noting the cardiac tamponade.The event occurred during mapping phase.Irrigated catheter flow setting was at 2cc ¿ idle.The correct catheter settings were selected on the generator but no ablation was performed.No error messages observed on biosense webster equipment during the procedure.Force visualization features were set at graph, dashboard, vector and visitag.The correct catheter settings selected on the generator.The webster ® cs catheter with ez steer¿ technology had slipped into the right ventricle while attempting to cannulate the coronary sinus.For this reason, the physician speculated that it was possible that the webster ® cs catheter with ez steer¿ technology may have caused perforation.Based on the available information, the event was assessed as mdr reportable under the webster ® cs catheter with ez steer¿ technology as there was no ablation performed and the physician speculated that it was possible that the webster ® cs catheter with ez steer¿ technology may have caused perforation.

• Brand Name: WEBSTER ® CS CATHETER WITH EZ STEER¿ TECHNOLOGY
• Common Device Name: ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez ; MX
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-7981
• MDR Report Key: 14604194
• Report Number: 2029046-2022-01207
• Device Sequence Number: 17388764
• Product Code: DRF
• UDI-Device Identifier: 10846835002430
• UDI-Public: 10846835002430
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K090898
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/24/2025
• Device Model Number: BD710FJ282RTS
• Device Catalogue Number: BD710FJ282RTS
• Device Lot Number: 30751210M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2022
• Initial Report FDA Received Date: 06/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: THMCL SMARTTOUCH,TC,J,C3; UNK_SMARTABLATE GENERATOR
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Female